Trial · NCT07274696
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Jitter | Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | Jitter reflects the regularity of the voice in terms of frequency. A smaller jitter value indicates higher regularity of the voice in terms of frequency. |
| Primary | Shimmer | Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | Shimmer reflects the regularity of the voice in terms of amplitude. A smaller shimmer value indicates higher regularity of the voice in terms of amplitude. |
| Primary | Fundamental frequency (F0) | Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | |
| Primary | Maximum Phonational Frequency Range (MPFR) | Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | The frequency range from the lowest to the highest pitch a person can produce (in Hz or semitones). |
| Primary | Noise-to-Harmonic Ratio (NHR) | Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | The NHR parameter is the ratio of non-harmonic components within the 1,500-4,500 Hz range to harmonic components within the 70-4,500 Hz range. It can be used to assess the proportion of noise components in the voice. |
| Secondary | The Voice Handicap Index-10 (VHI-10) | Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative | The VHI-10 is a voice disorder index scale containing 10 items, comprising 5 functional items, 3 physical items, and 2 emotional items. Each item is scored from 0 to 4, with different scores representing the frequency of occurrence for that item: "Never" is 0 points; "Almost Never" is 1 point; "Sometimes" is 2 points; "Almost Always" is 3 points; and "Always" is 4 points. A higher score indicates a greater impact of the voice disorder in that domain and a more severe self-assessment of the voice disorder by the subject. The critical value for the VHI-10 is 8 points, and subjects with a VHI score ≥ 8 are classified as having a voice disorder. |
| Secondary | The Voice-Related Quality of Life (V-RQOL-10) scale | Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative | Consists of 10 items, encompassing two domains: social-emotional and physical-functioning. The items describe the subjective experiences of patients with voice disorders. Severity is rated on a 5-point scale, where 1 represents "none," 2 represents "a little," 3 represents "a moderate amount," 4 represents "a lot," and 5 represents "a great deal." This questionnaire uses "reverse scoring," and the final scores need to be transformed to a 0 to 100 scale. A higher overall score indicates better voice-related quality of life, while a lower score indicates worse voice-related quality of life. |
| Secondary | The subjective auditory-perceptual assessment of voice quality (GRBAS Scale) | Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative | This scale consists of five parameters: overall grade of hoarseness (G), roughness (R), breathiness (B), asthenia (A), and strain (S). Each parameter is rated on a severity scale from 0 to 3: 0 indicates normal, 1 indicates mild deviation, 2 indicates moderate deviation, and 3 indicates severe deviation. A higher score represents a more severe voice disorder. The assessment is conducted by professional audiologists, voice specialists, and the patient's family members. |
| Secondary | Stroboscopy | Preoperative, If necessary after surgery | This examination utilizes the principle of persistence of vision to observe the vocal cords in a seemingly stationary or slow-motion vibrating state through visual superposition. Dynamic laryngoscopy is performed preoperatively, and the stroboscopic findings are recorded. Postoperatively, it is conducted on patients presenting with voice abnormalities, dysphonia, or suspected abnormal vocal cord mobility to confirm the mobility of the vocal cords. |
| Secondary | Intraoperative neural signals | Intraoperative | During the surgery, IONM technology was used to monitor neural signals from the vagus nerve, recurrent laryngeal nerve, and superior laryngeal nerve both before and after nerve exposure. |
| Secondary | The Eating Assessment Tool (EAT-10) | Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative | This instrument consists of 10 questions, with severity rated on a scale from 0 to 4. A score of 0 indicates "no problem," 1 indicates "mild," 2 indicates "moderate," 3 indicates "severe," and 4 indicates "very severe." A total score above 3 is generally considered indicative of abnormal swallowing function. |
| Secondary | Adverse Events | Within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative | At each follow-up visit, adverse events (including adverse drug reactions) were recorded through patient interviews and physical examinations. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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